Trial · NCT00088374
17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease
NCT00088374, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease. Trials, record NCT00088374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088374
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 17AAG to Treat Kidney Tumors in Von Hippel-Lindau Disease
- NCT number
- NCT00088374
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hippel-Lindau Disease, Kidney Cancer
- Interventions
- 17 allylamino-17-demethoxygeldanamycin, 18 FDG (Fludeoxyglucose 18F), [15-O] H2O, EPL diluent
- First posted
- 2004-07-26
- Last updated
- 2012-07-27
- Results first posted
- 2011-09-29
- Limitations and caveats
- Study did not meet accrual.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Renal Tumor Response | 12 weeks | Response is defined as the number of patients who experience a disease response (complete response (CR) or partial response (PR) of renal tumors)per RECIST criteria. CR is the disappearance of all target lesions. PR is at least a 20% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. See the protocol Link module for the full criteria if desired. |
| Secondary | Number of Participants With a Non-renal Tumor Response | Baseline and 12 weeks | Number of patients who have a PR or CR of non-renal lesions (pancreatic tumors, pheochromocytomas, and hemangioblastomas). The effect of treatment on the lesions will be evaluated at baseline and at the time of restaging (12 weeks) per RECIST criteria. RECIST is defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesions. Lesions are either measurable or non-measurable using the criteria. See the protocol Link module for the full criteria if desired. |
| Secondary | The Number of Participants With Adverse Events | 1 yr, 364 days | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. For a detailed description see the link in the Protocol Link module. |
| Secondary | The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes | Baseline and 12 weeks | Measurement of HIF, HSP90 and HSP70 levels by Western Blot in tumor tissue and/or lymphocytes to assess modulation of these biomarkers in response to 17 AAG treatment. Pretreatment tumor samples (when available) and resected tumors (in those patients who did not have a response and underwent surgical resection of their tumor) were to be used for this analysis. Levels of Hsp90, Hsp70, HIF and HIF transcriptional targets in resected tumor will be compared to respective levels in tumors previously resected from other VHL patients (not treated with 17AAG). |
| Secondary | Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake | Baseline and at 12 weeks | Images were acquired after the intravenous administration of 18FDG and H2015 and used to analyze glucose uptake and estimate blood flow. The parameter to be measured is SUV (standard uptake value(s)) and/or mL/min/gm. |
| Secondary | Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor | Baseline and during therapy (12 weeks) | Dynamic images will be acquired before and after the intravenous administration of 0.1 mmol/kg of Gadolinium Diethylene triamine pentaacetic acid (DTPA). Time activity curves will be generated over a period of ten minutes. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters we had previously defined (Ktrans, Kep, etc.). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Renal Tumor Response | 12 weeks | 8 patients were evaluable (received at least one dose of drug and had a follow up scan). | participants | NUMBER |
| SECONDARY | Number of Participants With a Non-renal Tumor Response | Baseline and 12 weeks | There were only two patients with measurable nonrenal tumors and hence the number of participants analyzed is correct. | participants | NUMBER |
| SECONDARY | The Number of Participants With Adverse Events | 1 yr, 364 days | participants | NUMBER | |
| SECONDARY | The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes | Baseline and 12 weeks | This analysis was not performed as it was felt that there were not a sufficient number of samples to enable a meaningful analysis. | ||
| SECONDARY | Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake | Baseline and at 12 weeks | Response was not the endpoint. The SUV values were in the 2-3 range and hence renal tumors could not be clearly identified by this technique in any of the patients. | participants | NUMBER |
| SECONDARY | Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor | Baseline and during therapy (12 weeks) | It is not the magnitude of changes in Ktrans, Kep, and Ve that limit our abililty, but the fact that this data was available in only a small number of patients. | participants with changes | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Renal Tumor Response | Participants With VHL Associated Renal Tumors | 0 | participants | ||
| Number of Participants With a Non-renal Tumor Response | Participants With VHL Associated Renal Tumors | 0 | participants | ||
| The Number of Participants With Adverse Events | Participants With VHL Associated Renal Tumors | 9 | participants | ||
| Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake | Participants With VHL Associated Renal Tumors | 0 | participants | ||
| Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor | Participants With VHL Associated Renal Tumors | 3 | participants with changes |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VHL Associated Renal Tumors | 9 | |
| Overall Study | COMPLETED | VHL Associated Renal Tumors | 7 | |
| Overall Study | NOT COMPLETED | VHL Associated Renal Tumors | 2 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | Participants With VHL Associated Renal Tumors | 3 | 9 | 3 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Investigations | Participants With VHL Associated Renal Tumors | 1 | 9 | 1 |
| other | BLOOD/BONE MARROW:: Leukocytes (total WBC) | Investigations | Participants With VHL Associated Renal Tumors | 1 | 9 | 2 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Investigations | Participants With VHL Associated Renal Tumors | 1 | 9 | 2 |
| other | CARDIAC ARRHYTHMIA:: Conduction abnormality/atrioventricular heart block:: AV Block-First degree | Cardiac disorders | Participants With VHL Associated Renal Tumors | 1 | 9 | 5 |
| other | CARDIAC ARRHYTHMIA:: Conduction abnormality/atrioventricular heart block:: AV Block-Second degree Mo | Cardiac disorders | Participants With VHL Associated Renal Tumors | 1 | 9 | 1 |
| other | CARDIAC ARRHYTHMIA:: Palpitations | Congenital, familial and genetic disorders | Participants With VHL Associated Renal Tumors | 1 | 9 | 1 |
| other | CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia | Cardiac disorders | Participants With VHL Associated Renal Tumors | 3 | 9 | 14 |
| other | CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia | Cardiac disorders | Participants With VHL Associated Renal Tumors | 1 | 9 | 1 |
| other | CARDIAC ARRHYTHMIA:: Ventricular arrhythmia:: Ventricular tachycardia | Cardiac disorders | Participants With VHL Associated Renal Tumors | 1 | 9 | 2 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With VHL Associated Renal Tumors | ||
| Total, other adverse events | Participants With VHL Associated Renal Tumors | 8 | 9 |
| Total, serious adverse events | Participants With VHL Associated Renal Tumors | 1 | 9 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00088374
GET https://conductscience.org/api/trials/v1/NCT00088374/events?page=2